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FUJISAWA USA PROGRAF (FK-506) TRANSPLANT ANTI-REJECTION DRUG NDAs FILED

Executive Summary

FUJISAWA USA PROGRAF (FK-506) TRANSPLANT ANTI-REJECTION DRUG NDAs FILED the week of Sept. 1, the company announced Sept. 7. Fujisawa filed separate NDAs for the immunosuppressant Prograf (tacrolimus) in intravenous and capsule forms. The company is seeking an indication for prevention of organ transplant rejection focusing initially on use in liver transplantation. The NDAs are based on two multi-center studies of Prograf in liver transplant patients. Data from the trials were reported in May at the American Society of Transplant Surgeons in Houston. The trials enrolled 520 patients at 12 U.S. centers and 545 patients at eight European centers, Fujisawa USA said. In the U.S. study, FK-506 resulted in five times fewer rejections resistant to treatment than did a regimen of therapy employing Sandoz' Sandimmune (cyclosporin). Fujisawa recently launched Prograf in Japan in 1 mg capsules and 5 mg injections. The recommended dose in Japan is .15 mg/kg for initiating therapy with a maintenance dose of .10 mg/kg. It is indicated in Japan for suppression of rejection in liver transplantation. Among tacrolimus' characteristics, Fujisawa said, is that it "allows for sparing use or removal of adjunctive steroid treatment in almost all patients." Fujisawa USA's ongoing compliance problems at its Deerfield, Ill. facilities acquired from Lyphomed will not affect the review of Prograf, the company said. The bulk drug will be manufactured by Fujisawa in Toyama, Japan and the finished dosage form will be manufactured in Killorglin, Ireland. Fujisawa is ineligible for approvals under FDA's applications integrity policy pending the outcome of a validity assessment at the former Lyphomed facilities ("The Pink Sheet" May 10, T&G-12). Fujisawa USA said it has completed the validity assessment and is awaiting response from FDA. Fujisawa USA announced Sept. 8 that it has consolidated its Fujisawa and Lyphomed sales forces into an integrated marketing unit. The restructured sales force numbers about 100, Fujisawa USA said. The consolidated sales force will remain under the direction of VP-Sales & Marketing Patrick Walsh. Former American Healthcare Systems Purchasing Partners VP and Pharmacy Services Director James Herrick has joined Fujisawa USA as senior director of market planning. The new organization will have "a customer focus, replacing the traditional product orientation," Fujisawa said. "This will allow customers to see one sales representative for all their multi-source and proprietary product needs." The integration also eliminates the last unit operating under the Lyphomed name; Fujisawa integrated its manufacturing and administrative operations earlier this year ("The Pink Sheet" March 15, In Brief).
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